CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 241 enrolled
Drug / intervention
Calcium carbonate +1 moredrug
Likely dose
Teriparatide (dose not specified in interventions) with calcium carbonate or calcium phosphate and vitamin DAI-extracted
Key inclusion· 6
  • Bone mineral density T-score less than -1.0
  • One or more vertebral fractures
  • Serum creatinine less than 1.3 mg/dL
  • Serum phosphorus less than 3.6 mg/dL
Key exclusion· 6
  • Paget's disease or history of osteosarcoma
  • Systemic corticosteroid therapy
  • Hyperparathyroidism
  • Recent history of kidney stone

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00074711
NCT00074711Phase 2Completed

Bone Sparing by Calcium Salts With and Without Extra Phosphorus

Creighton University·interventional·Posted Dec 22, 2003·Updated Jul 6, 2016

In Brief

A Phase 2 clinical trial evaluating Calcium carbonate and Calcium Phosphate for Osteoporosis and Osteopenia. Completed, enrolled 241 participants across 1 site.

Detailed Summary

Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus available for bone building. Teriparatide is a drug that reduces the risk of fractures by increasing bone thickness and strength. Vitamin D is also necessary for strong bones and teeth. The purpose of this study is to evaluate the bone-building effectiveness of two calcium supplements, one with a source of phosphorus and one without, in combination with teriparatide and vitamin D in women with osteoporosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 22, 2003
Enrollment StartAug 1, 2004
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 22.5 years ago

Interventions

Calcium carbonatedrug

Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.

Calcium Phosphatedrug

Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.